An observational study in Procedural Pain, Procedural Sedation and Analgesia and Intracranial Pressure, sponsored by Ankara Etlik City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Ankara Etlik City Hospital · Observational
The goal of this observational study is to learn whether ketamine given for procedural analgesia changes intracranial pressure in adult emergency department patients. Intracranial pressure is assessed non-invasively by measuring optic nerve sheath diameter (ONSD) with bedside ultrasonography. The main questions it aims to answer are:
This prospective observational study is conducted in the Emergency Department of Ankara Etlik City Hospital. Adult patients who receive intravenous ketamine for procedural analgesia are enrolled consecutively after written and verbal informed consent. The decision to use ketamine and the dose (0.5 mg/kg or 1 mg/kg) are made by the treating emergency physician as part of routine care; the study does not assign, change, or interfere with any treatment. Patients are grouped according to the ketamine dose they receive.
Optic nerve sheath diameter (ONSD) is measured with bedside ocular ultrasonography immediately before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration. Systolic and diastolic blood pressure, heart rate, oxygen saturation, body temperature, and pain intensity (Numeric Rating Scale) are recorded at the same time points. Adverse events related to ketamine are recorded during the 30-minute observation period. Ocular ultrasonography is the only study-specific procedure; it is non-invasive and painless. The planned sample size is 160 patients.
245 studies on the registry are indexed under Pain, Procedural; 66 are open to participants now.
This study's planned enrollment of 160 is below the median of 180 across 15 observational studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Ankara Etlik City Hospital is the lead sponsor of 174 studies on the registry; 75 are open to participants now.
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Adult patients (aged 18 years or older) presenting to the Emergency Department of Ankara Etlik City Hospital who receive intravenous ketamine for procedural analgesia as part of routine care.
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Exclusion Criteria:
Adult emergency department patients who receive intravenous ketamine 0.5 mg/kg for procedural analgesia, with the dose chosen by the treating physician as part of routine care.
Drug: ketamine
Adult emergency department patients who receive intravenous ketamine 1 mg/kg for procedural analgesia, with the dose chosen by the treating physician as part of routine care.
Drug: ketamine
Intravenous ketamine given for procedural analgesia as part of routine emergency care. The dose (0.5 mg/kg or 1 mg/kg) is chosen by the treating physician; the study does not assign or modify treatment.
Also known as: ketalar, Ketamine hydrochloride
Change in Optic Nerve Sheath Diameter From Baseline
Optic nerve sheath diameter (ONSD, mm) measured by bedside ocular ultrasonography as a non-invasive indicator of intracranial pressure. Change from the pre-ketamine measurement (minute 0) is assessed at each time point after ketamine administration.
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Optic Nerve Sheath Diameter by Ketamine Dose
Change in ONSD (mm) from minute 0, compared between patients receiving 0.5 mg/kg and 1 mg/kg ketamine.
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Systolic Blood Pressure
Systolic blood pressure (mmHg) measured non-invasively.
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Diastolic Blood Pressure
Diastolic blood pressure (mmHg) measured non-invasively.
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
"Change in Heart Rate
Heart rate (beats per minute).
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Oxygen Saturation
Peripheral oxygen saturation (%) measured by pulse oximetry.
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Pain Intensity
Pain intensity measured with the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate more severe pain.
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Number of Participants With Ketamine-Related Adverse Events
Adverse events attributed to ketamine, observed and recorded by the investigators.
Time frame: From ketamine administration to 30 minutes after administration
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Plan to share: No — Individual participant data will not be shared. In accordance with the ethics committee approval, study data are accessible only to the study investigators
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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